Senior Manager, Operational Excellence

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.

The Senior Manager Operational Excellence will be responsible for designing, developing and implementing a site-wide Lean Manufacturing Systems for the new Kyowa Kirin Manufacturing site in Sanford, NC. The incumbent will provide expertise and leadership in both Lean and Six Sigma methodologies to help enable the business towards its goals. They will be responsible for leading cross functional teams and executing comprehensive lean manufacturing strategies and tools across the manufacturing facility, leading continuous improvement initiatives, identifying and eliminating waste, optimizing processes, and driving operational efficiency while ensure alignment with company goals and quality standards. 

As a people leader, you will embody compassionate, people-centric leadership to guide and support our team. You will collaborate closely with others, fostering a collaborative, inclusive, and supportive environment while driving team development. Your work will reflect the organization’s values and integrity in all your actions. Utilizing situational leadership and emotional intelligence, you will align diverse viewpoints, manage stakeholders, and make empathetic decisions to address individual and team needs effectively. You will also be results-oriented, ensuring that your team not only adapts to challenges but also delivers measurable outcomes that align with business objectives. Additionally, you will help teams navigate through change and uncertainty with resilience and clarity, enabling them to adapt to fast-evolving, rapidly scaling environments and meet new challenges in the biotech industry with a patient-focused mindset.

This position reports to the Director of Manufacturing

Technical Skills, Knowledge, and Experience 
•    Strategic Leadership: Design, develop and implement a comprehensive lean manufacturing system aligned with overall business objectives. Create and scale operational excellence program and standards. Establish clear performance metrics and targets for lean initiatives across the manufacturing facility. Champion a culture of continuous improvement and lean thinking throughout the organization. 
•    Process Improvement: Identify and analyze areas for process improvement using lean tools like value stream mapping, 5S, and root cause analysis. Lead cross-functional teams to design and implement process improvements, eliminating waste and optimizing workflows. Lead Kaizen events to rapidly identify and address operational inefficiencies. 
•    Team Management: Develop and mentor a team of lean specialists and process improvement leaders. Empower teams to take ownership of lean initiatives and drive results. Foster collaboration and knowledge sharing across departments. 
•    Performance Monitoring and Reporting: Track key performance indicators (KPIs) related to lean initiatives, including cycle time, lead time, and defect rates. Regularly report on progress and identify areas for further optimization to senior management. 
•    Change Management: Communicate lean methodologies and benefits clearly to all levels of the organization. Manage change effectively to ensure successful implementation of lean practices. 

Leadership
•    Results-Oriented: Lead teams by setting clear, measurable goals and ensuring accountability for achieving key objectives. Align resources effectively, remove obstacles, and maintain focus on delivering high-quality results within set timelines.
•    Empathetic Communication: Listen carefully, give helpful feedback, and handle conflicts with care.
•    Team Development: Mentor and guide team members, create growth plans, support ongoing learning, and develop the team with a patient-focused mindset.
•    Inclusive Leadership: Build a diverse, respectful environment where everyone feels valued and supported.
•    Supportive Environment: Encourage a positive workplace, celebrate achievements, and promote work-life balance.
•    Collaboration: Lead by example, promote teamwork and respect, and ensure your actions reflect the organization’s values.
•    Emotional Intelligence: Manage emotions thoughtfully, make empathetic decisions with a patient-focused mindset, and stay calm under pressure.
•    Change Management: Help teams navigate change with clear communication and flexibility.
•    Situational Leadership: Adapt your leadership style to meet the needs of the team, offering guidance or independence as needed, while keeping patient outcomes in mind.
•    Stakeholder Management and Alignment Building: Work with different people to build alignment, guide discussions toward common goals, and ensure decisions are aligned with a patient-focused mindset.

Continuous Improvement Specialists 

Education
•    Bachelors degree in engineering or life sciences.

Experience
•    Minimum of 5 years of experience, preferably in bio-pharmaceutical manufacturing
•    Six Sigma and/or Lean Green Belt certification by a recognized third-party and supported by execution of a green belt project.
•    Demonstrated experience with deploying lean manufacturing systems,
•    Demonstrated use of project management methodologies including agile.
•    Knowledge/experience in Continuous Improvement programs and Change Management practices.
•    Experience with starting up and operating a biopharma manufacturing facility is a plus.

Technical Skills
•    Deep Expertise in Lean Manufacturing: Thorough understanding of lean principles, tools, and methodologies like 5S, Standard Work, Visual Management, Kanban, Error Proofing and Six Sigma. 
•    Leadership and Team Building: Proven ability to lead and motivate cross-functional teams globally to achieve results. 
•    Problem-Solving Skills: Excellent analytical skills to identify root causes of problems and develop effective solutions. 
•    Communication and Stakeholder Management: Strong communication skills to effectively engage with diverse stakeholders across the organization. 
•    Project Management: Proven ability to manage complex improvement projects from initiation to completion. 

Non-Technical Skills
Results-oriented and able to navigate ambiguity, you set clear outcomes, track progress, follow through on commitments, and ensure your actions lead to measurable results that advance organizational objectives. Respond promptly, take accountability, and manage tasks efficiently. Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges. Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment. Communicate with care by actively listening and considering others' perspectives, fostering productive, engaging interactions, and managing relationships with kindness. Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset. Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. Contribute positively by recognizing achievements and encouraging a healthy work-life balance. Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain. Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions. Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.

Initially working on a construction site and ultimately in a biotech manufacturing site in Sanford, NC.

Work is 100% on-site.  This is not a hybrid or remote role.  

Requires up to 10% domestic and limited international travel. 

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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